This chapter explores the quality management system re-prioritization efforts employed by Rapid Acceleration of Diagnostics (RADx®)-supplied content experts to support rapid product development and commercialization of COVID-19 diagnostic tests. The chapter also explores the interplay between quality, development, manufacturing, and risk management. While the chapter is applicable to companies of all sizes, particular emphasis is placed on describing a roadmap for small businesses and start-ups without the mature quality management systems and teams in place that a larger company may have.

Many parameters are associated with IHC testing assays. With so many variables, it is quite easy to accumulate errors within the system. To make things more manageable, these considerations are categorized into three main groups. Pre-analytic aspects occur before the assay, analytic factors are concerned with the staining protocol and post-analytic elements relate to interpreting of results. It has also come to reason that any one variable can impact the reliability and consistency of the overall IHC assay. In this regard, standardization requirements have been enlisted to assist laboratories achieve optimal results. In addition, monitoring proficiency testing regimens and various organizations are in place to ensure high levels of standards are attained. All these endeavours are known as quality assurance and quality control measures. They are arranged under the overall umbrella of a facility’s quality management system.